Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.
NCT ID: NCT01961609
Last Updated: 2019-03-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2013-10-09
2016-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
NCT03066609
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
NCT01806597
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
NCT01900782
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
NCT02008890
Plaque Psoriasis Efficacy and Safety With Secukinumab
NCT02409667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Numerous double-blind, double-dummy, randomised, parallel-group, active and placebo controlled studies have already been designed and run for the Phase III secukinumab clinical development program, in accordance with Health Authorities guidelines and feedback, including Food and Drug Administration (FDA) and European Medicines Agency (EMA). None of these specifically studied patients who have failed to respond to anti-TNFα therapy as defined by National Institute for Health and Care Excellence (NICE) guidelines.
Therefore, this study utilises a pragmatic, open-label, non-comparator design, which has been shown to be appropriate in similar studies looking at anti-TNFα therapy in patients failing on other therapies (Papp et al. 2012; Strober et al. 2011), to answer the question of whether secukinumab is an appropriate choice in patients who have failed to respond to anti-TNFα therapy (TNF-IR) per NICE definitions, whether a single anti-TNFα therapy failure or multiple anti-TNFα therapy failures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Secukinumab (AIN457) 300 mg
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
Secukinumab (AIN457)
Secukinumab was supplied in 150mg pre-filled syringes.
Secukinumab (AIN457) 150 mg
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg.
Secukinumab (AIN457)
Secukinumab was supplied in 150mg pre-filled syringes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Secukinumab (AIN457)
Secukinumab was supplied in 150mg pre-filled syringes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged at least 18 years at screening
3. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
4. Moderate to severe disease severity:
* PASI ≥10 and
* DLQI \>10
5. Failed to respond to systemic therapies including cyclosporine and/or methotrexate and/or PUVA (or is intolerant and/or has a contraindication to these)
6. Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder
7. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion Criteria
2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
3. Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids (CS), UV therapy). Washout periods detailed in the protocol must be adhered to.
4. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before initiation of study drug.
5. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
8. Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
9. Active systemic infections during the last two weeks (exception: common cold) prior to initiation of study drug and any infections that reoccur on a regular basis; investigator discretion should be used regarding patients who have travelled or recently resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis and for patients with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes
10. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to UK guidelines.
11. Known infection with HIV, hepatitis B or hepatitis C at screening or at initiation of study drug.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Cork, , Ireland
Novartis Investigative Site
Dublin, , Ireland
Novartis Investigative Site
Dublin, , Ireland
Novartis Investigative Site
Plymouth, Devon, United Kingdom
Novartis Investigative Site
London, England, United Kingdom
Novartis Investigative Site
Harlow, Essex, United Kingdom
Novartis Investigative Site
London, GBR, United Kingdom
Novartis Investigative Site
Canterbury, Kent, United Kingdom
Novartis Investigative Site
Dafen, Llanelli, United Kingdom
Novartis Investigative Site
Salford, Manchester, United Kingdom
Novartis Investigative Site
Cliftonville, Northampton, United Kingdom
Novartis Investigative Site
Nottingham, Nottinghamshire, United Kingdom
Novartis Investigative Site
Aberdeen, Scotland, United Kingdom
Novartis Investigative Site
Yeovil, Somerset, United Kingdom
Novartis Investigative Site
Cardiff, South Glamorgan, United Kingdom
Novartis Investigative Site
Staffordshire, Staffordshire, United Kingdom
Novartis Investigative Site
Ipswich, Suffolk, United Kingdom
Novartis Investigative Site
Frimley, Surrey, United Kingdom
Novartis Investigative Site
Surrey, Surrey, United Kingdom
Novartis Investigative Site
Rhyl, Wales, United Kingdom
Novartis Investigative Site
Coventry, Warwickshire, United Kingdom
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Airdrie, , United Kingdom
Novartis Investigative Site
Bath, , United Kingdom
Novartis Investigative Site
Belfast, , United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Chester, , United Kingdom
Novartis Investigative Site
Durham, , United Kingdom
Novartis Investigative Site
Fife, , United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Hull, , United Kingdom
Novartis Investigative Site
Lancaster, , United Kingdom
Novartis Investigative Site
Leicester, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Middlesbrough, , United Kingdom
Novartis Investigative Site
Middlesex, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Novartis Investigative Site
Norwich, , United Kingdom
Novartis Investigative Site
Nottingham, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Novartis Investigative Site
Poole, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Novartis Investigative Site
Scaroborough, , United Kingdom
Novartis Investigative Site
Scunthorpe, , United Kingdom
Novartis Investigative Site
Stoke-on-Trent, , United Kingdom
Novartis Investigative Site
Surrey, , United Kingdom
Novartis Investigative Site
Wrexham, , United Kingdom
Novartis Investigative Site
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAIN457AGB01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.